An Internet-based Self Applied Treatment Program for Prolonged Grief Disorder (PGD)

Universitat Jaume I6 enrolled

Overview

The purpose os this study is examine the effect and feasibility (usability and satisfaction) of an iCBT (GROw program) for adults with PGD

The death of a loved one has physical, psychological, and social consequences. Between 9.8 and 21.5% of people who lose a loved one develop Prolonged Grief Disorder (PGD). Internet- and computer-based interventions (i.e., Internet-delivered Cognitive-Behavioral Therapy, iCBT) are cost-effective and scalable alternatives that make it possible to reach more people with PGD. The main goal of the present investigation was to examine the effect and feasibility (usability and satisfaction) of an iCBT (GROw program) for adults with PGD. A secondary objective was to detect adherence to the app (Emotional Monitor) used to measure daily grief symptoms. The study had a single-case multiple-baseline AB design with six participants. The GROw program is organized sequentially in eight modules, and it is based on the dual-process model of coping with bereavement. Evaluations included a pre-to-post treatment assessment of depression, grief symptoms, and typical grief beliefs, along with daily measures of symptom frequency and intensity on the Emotional Monitor App. Treatment opinions and adherence to the App were also collected. Efficacy data were calculated using a Nonoverlap of All Pairs (NAP) analysis and Reliable Change Index (RCI).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Grief

Interventions

GROw: An Internet based Self Applied Treatment Program for Prolonged Grief Disorder (PGD)BEHAVIORAL

It is a self-applied treatment through the web "psicologíaytecnología.labpsitec.es". There are 8 treatment modules. Each module lasts approximately 60 minutes. It contains written information, videos, audios, photos and interactive questionnaires. The total duration of treatment is 8-10 weeks. A support call will be made a week (maximum 10 minutes) to answer questions and reinforce and motivate the patient. No additional clinical content or counselling will be provided. Main components of the treatment: Motivation for change, Psychoeducation, Behavioral activation, Exposure, Mindfulness and compassion strategies, integration of loss, restoration and reconstruction of meaning, Cognitive reappraisal and Relapse prevention

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age ≥ 18 years * Meeting diagnostic criterio for PGD * Sign an informed consent * Ability to understand and read Spanish * Abilitiy to use a computer and having access to the Internet * Having an e-mail address Exclusion Criteria: * Presence of risk of suicide or self-destructive behaviors * Presence of another severe mental disorder (substance abuse or dependence, pshychotic disorder, dementia o bipolar disorder) * Presence of severe personality disorder * Presence of a medical condition whose severity or characteristics prevent the performance of treatment * Receiving other psychological treatment during the study for PGD * An increase and/or change in the medication during the study period

Locations (1)

Universitat Jaume I

Castellon, Castellón, Spain

Outcomes

Primary Outcomes

Change in Emotional Pain: intensity of sadness, anger, anxiety, guilt and grief

\* Evaluation from mobile app Item 1: In relation to the death of your loved one; What intensity of sadness have you felt TODAY? Item2: In relation to the death of your loved one; What intensity of anger have you felt TODAY? Item 3: In relation to the death of your loved one; What intensity of anxiety have you felt TODAY? Item 4: In relation to the death of your loved one; What intensity of guilt have you felt TODAY? Item 5: In relation to the death of your loved one; What intensity of pain from loss have you felt TODAY? \* Evaluation from mobile app

Time frame: Once a day (from the start of the baseline until the end of the treatment) and at 3 and 12 months after the end of the treatment

Secondary Outcomes

Change in frequency of sad memories

Item: How often have you remembered TODAY the absence of your loved one with enormous and deep sadness? \* Evaluation from mobile app

Time frame: Once a day (from the start of the baseline until the end of the treatment) and at 3 and 12 months after the end of the treatment

Change in frequency of memories that produce anger

Item: How often have you remembered TODAY the absence of your loved one with a huge and deep anger? \* Evaluation from mobile app

Time frame: Once a day (from the start of the baseline until the end of the treatment) and at 3 and 12 months after the end of the treatment

Change in frequency of memories that produce anxiety

Item: How often have you remembered TODAY the absence of your loved one with enormous and deep anxiety? \* Evaluation from mobile app

Time frame: Once a day (from the start of the baseline until the end of the treatment) and at 3 and 12 months after the end of the treatment

Change in frequency of memories that produce guilt

Data from ClinicalTrials.gov

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